ES2722201T3 - Composiciones y procedimientos útiles para estabilizar formulaciones que contienen proteínas - Google Patents

Composiciones y procedimientos útiles para estabilizar formulaciones que contienen proteínas Download PDF

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Publication number
ES2722201T3
ES2722201T3 ES11711232T ES11711232T ES2722201T3 ES 2722201 T3 ES2722201 T3 ES 2722201T3 ES 11711232 T ES11711232 T ES 11711232T ES 11711232 T ES11711232 T ES 11711232T ES 2722201 T3 ES2722201 T3 ES 2722201T3
Authority
ES
Spain
Prior art keywords
compositions
containing formulations
stabilizing protein
procedures useful
protein
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
ES11711232T
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English (en)
Spanish (es)
Inventor
Junyan Ji
Jun Liu
Yuchang John Wang
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Original Assignee
F Hoffmann La Roche AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Application granted granted Critical
Publication of ES2722201T3 publication Critical patent/ES2722201T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • C07K16/4291Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
ES11711232T 2010-03-22 2011-03-21 Composiciones y procedimientos útiles para estabilizar formulaciones que contienen proteínas Active ES2722201T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US31632610P 2010-03-22 2010-03-22
PCT/US2011/029206 WO2011119487A2 (fr) 2010-03-22 2011-03-21 Compositions et procédés utiles pour stabiliser les formulations contenant des protéines

Publications (1)

Publication Number Publication Date
ES2722201T3 true ES2722201T3 (es) 2019-08-08

Family

ID=43977896

Family Applications (1)

Application Number Title Priority Date Filing Date
ES11711232T Active ES2722201T3 (es) 2010-03-22 2011-03-21 Composiciones y procedimientos útiles para estabilizar formulaciones que contienen proteínas

Country Status (16)

Country Link
US (3) US9662395B2 (fr)
EP (2) EP2550018B1 (fr)
JP (3) JP5937059B2 (fr)
KR (3) KR101878369B1 (fr)
CN (3) CN103124564B (fr)
BR (1) BR112012021873B8 (fr)
CA (2) CA3027749A1 (fr)
ES (1) ES2722201T3 (fr)
HK (1) HK1216842A1 (fr)
HR (1) HRP20190751T1 (fr)
MX (1) MX354867B (fr)
PL (1) PL2550018T3 (fr)
RU (1) RU2584232C2 (fr)
SI (1) SI2550018T1 (fr)
TR (1) TR201905081T4 (fr)
WO (1) WO2011119487A2 (fr)

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CN104039826A (zh) * 2011-10-31 2014-09-10 弗·哈夫曼-拉罗切有限公司 抗体制剂
KR102372245B1 (ko) * 2013-11-21 2022-03-08 젠맵 에이/에스 항체-약물 접합체 동결건조 제제
BR112016024088A2 (pt) 2014-04-16 2018-06-19 Biocon Ltd. formulações de proteína estáveis que compreendem um excesso molar de sorbitol
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EP3053572A1 (fr) * 2015-02-06 2016-08-10 Ares Trading S.A. Composition pharmaceutique liquide
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CN106771148B (zh) * 2016-12-28 2018-03-06 广州华弘生物科技有限公司 一种免疫球蛋白m检测试剂盒及检测方法
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CN111964942A (zh) * 2020-08-28 2020-11-20 湖南海尚仪器设备有限公司 基于工业环境污染物检测的采样方法
CA3196481A1 (fr) * 2020-11-16 2022-05-19 W. L. Gore & Associates, Inc. Formulations, procedes et dispositifs d'injection multi-dose pre-remplis sans point de trouble
CN112816684A (zh) * 2021-01-07 2021-05-18 武汉华美生物工程有限公司 血清淀粉样蛋白a的校准品稀释液、其制备方法及其应用

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Also Published As

Publication number Publication date
JP6791929B2 (ja) 2020-11-25
JP2019048831A (ja) 2019-03-28
BR112012021873B8 (pt) 2021-09-14
MX2012010612A (es) 2012-10-03
KR101878369B1 (ko) 2018-07-16
CN106983862A (zh) 2017-07-28
WO2011119487A2 (fr) 2011-09-29
RU2012144626A (ru) 2014-04-27
US20200023063A1 (en) 2020-01-23
MX354867B (es) 2018-03-23
HK1216842A1 (zh) 2016-12-09
KR102218495B1 (ko) 2021-02-19
CA3027749A1 (fr) 2011-09-29
CN103124564A (zh) 2013-05-29
BR112012021873B1 (pt) 2021-05-11
HRP20190751T1 (hr) 2019-06-14
EP3513810A1 (fr) 2019-07-24
KR20180000342A (ko) 2018-01-02
JP5937059B2 (ja) 2016-06-22
US9662395B2 (en) 2017-05-30
EP2550018A1 (fr) 2013-01-30
KR20130010466A (ko) 2013-01-28
CA2792125C (fr) 2019-02-12
TR201905081T4 (tr) 2019-05-21
EP2550018B1 (fr) 2019-02-27
CN103124564B (zh) 2016-11-09
US20170224820A1 (en) 2017-08-10
JP6742805B2 (ja) 2020-08-19
WO2011119487A3 (fr) 2013-05-10
CN104998269B (zh) 2019-06-11
SI2550018T1 (sl) 2019-05-31
CA2792125A1 (fr) 2011-09-29
BR112012021873A2 (pt) 2016-05-24
JP2013527832A (ja) 2013-07-04
RU2584232C2 (ru) 2016-05-20
US20130078232A1 (en) 2013-03-28
KR20190104254A (ko) 2019-09-06
CN104998269A (zh) 2015-10-28
PL2550018T3 (pl) 2019-08-30
JP2016193909A (ja) 2016-11-17

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